Recomendaciones sobre el manejo clínico de la alopecia androgénica: un documento de consenso del Grupo Español de Tricología de la Academia Española de Dermatología y Venereología / Recommendations on the Clinical Management of Androgenetic Alopecia: A Consensus Statement From the Spanish Trichology Group of the Spanish Academy of Dermatology and Venererology (AEDV)

El tratamiento de la alopecia androgénica (AGA) puede ser complejo para el clínico debido a la amplia gama de terapias disponibles, en muchos casos con escasos ensayos clínicos disponibles, y con muchas de las opciones de tratamiento sin aprobación de uso en la AGA según su ficha técnica. Este documento de consenso sobre el manejo de la AGA se ha elaborado siguiendo un método Delphi, en el que han participado 34 dermatólogos miembros del Grupo Español de Tricología de la Academia Española de Dermatología y Venereología. Tras 2 rondas de votaciones, se consensuaron 138 de los 160 ítems propuestos (86%), estructurados en 4 bloques de recomendaciones: generalidades, tratamiento farmacológico, procedimientos y trasplante capilar, y casos especiales. Este documento de consenso se apoya en la evidencia científica disponible y en la opinión de expertos para ayudar a los profesionales en el manejo de la AGA en la práctica clínica diaria.(AU)

Androgenetic alopecia can be challenging to treat due to the wide range of available treatments, most of which are not based on evidence from clinical trials. In addition many of the options do not include androgenetic alopecia among the approved indications according to their summaries of product characteristics. A panel of 34 dermatologists from the Spanish Trichology Society of the Spanish Academy of Dermatology and Venereology (AEDV) used the Delphi method to develop a consensus statement on the management of androgenetic alopecia. Over a 2-round process the experts agreed on 138 (86%) of the 160 proposed items, which were structured into 4 blocks of recommendations: general considerations, pharmacologic treatment, procedures and hair transplant, and special cases. The resulting consensus statement based on expert opinion of the scientific evidence can guide professionals in the routine management of androgenetic alopecia.(AU)

[Translated article] Recommendations on the Clinical Management of Androgenetic Alopecia: A Consensus Statement From the Spanish Hair Disorders Group of the Spanish Academy of Dermatology and Venererology (AEDV) / Recomendaciones sobre el manejo clínico de la alopecia androgénica: un documento de consenso del Grupo Español de Tricología de la Academia Española de Dermatología y Venereología

El tratamiento de la alopecia androgénica (AGA) puede ser complejo para el clínico debido a la amplia gama de terapias disponibles, en muchos casos con escasos ensayos clínicos disponibles, y con muchas de las opciones de tratamiento sin aprobación de uso en la AGA según su ficha técnica. Este documento de consenso sobre el manejo de la AGA se ha elaborado siguiendo un método Delphi, en el que han participado 34 dermatólogos miembros del Grupo Español de Tricología de la Academia Española de Dermatología y Venereología. Tras 2 rondas de votaciones, se consensuaron 138 de los 160 ítems propuestos (86%), estructurados en 4 bloques de recomendaciones: generalidades, tratamiento farmacológico, procedimientos y trasplante capilar, y casos especiales. Este documento de consenso se apoya en la evidencia científica disponible y en la opinión de expertos para ayudar a los profesionales en el manejo de la AGA en la práctica clínica diaria.(AU)

Androgenetic alopecia can be challenging to treat due to the wide range of available treatments, most of which are not based on evidence from clinical trials. In addition many of the options do not include androgenetic alopecia among the approved indications according to their summaries of product characteristics. A panel of 34 dermatologists from the Spanish Trichology Society of the Spanish Academy of Dermatology and Venereology (AEDV) used the Delphi method to develop a consensus statement on the management of androgenetic alopecia. Over a 2-round process the experts agreed on 138 (86%) of the 160 proposed items, which were structured into 4 blocks of recommendations: general considerations, pharmacologic treatment, procedures and hair transplant, and special cases. The resulting consensus statement based on expert opinion of the scientific evidence can guide professionals in the routine management of androgenetic alopecia.(AU)

[Translated article] Recommendations on the Clinical Management of Androgenetic Alopecia: A Consensus Statement From the Spanish Hair Disorders Group of the Spanish Academy of Dermatology and Venererology (AEDV).

Androgenetic alopecia can be challenging to treat due to the wide range of available treatments, most of which are not based on evidence from clinical trials. In addition many of the options do not include androgenetic alopecia among the approved indications according to their summaries of product characteristics. A panel of 34 dermatologists from the Spanish Hair Disorders Society of the Spanish Academy of Dermatology and Venereology (AEDV) used the Delphi method to develop a consensus statement on the management of androgenetic alopecia. Over a 2-round process the experts agreed on 138 (86%) of the 160 proposed items, which were structured into 4 blocks of recommendations: general considerations, pharmacologic treatment, procedures and hair transplant, and special cases. The resulting consensus statement based on expert opinion of the scientific evidence can guide professionals in the routine management of androgenetic alopecia.

Safety of Low-Dose Oral Minoxidil in Patients With Hypertension and Arrhythmia: A Multicenter Study of 264 Patients / Seguridad de minoxidil oral a dosis bajas en pacientes con hipertensión o arritmias: estudio multicéntrico de 264 pacientes

Background and objective Systemic adverse effects (AE) are a major concern of low-dose oral minoxidil (LDOM) treatment, especially in patients with arterial hypertension or arrhythmia. The objective of this study was to evaluate the safety of LDOM in patients with hypertension or arrhythmia. Patients and methods Retrospective multicenter study of patients with hypertension or arrhythmia treated with LDOM for any type of alopecia. Results A total of 254 patients with hypertension [176 women (69.3%) and 78 men (30.7%)] with a mean age of 56.9 years (range 19–82) were included. From them, the dose of LDOM was titrated in 128 patients, allowing the analysis of 382 doses. Patients were receiving a mean of 1.45 (range 0–5) antihypertensive drugs. Systemic AE were detected in 26 cases (6.8%) and included lightheadedness (3.1%), fluid retention (2.6%), general malaise (0.8%), tachycardia (0.8%) and headache (0.5%), leading to LDOM discontinuation in 6 cases (1.5%). Prior treatment with doxazosin (P<0.001), or with three or more antihypertensive drugs (P=0.012) was associated with a higher risk of discontinuation of LDOM. Conclusions LDOM treatment showed a favorable safety profile in patients with hypertension or arrhythmia, similar to general population (AU)

Antecedentes y objetivo Los efectos adversos sistémicos son una de las principales limitaciones del uso de minoxidil oral a dosis bajas (MODB), especialmente en pacientes con hipertensión arterial o arritmias. El objetivo de este estudio fue evaluar la seguridad de MODB en estos pacientes. Material y método Estudio retrospectivo multicéntrico con pacientes con antecedentes de hipertensión o arritmias tratados con MODB para cualquier tipo de alopecia. Resultados Se incluyó un total de 254 pacientes con hipertensión (176 mujeres [69,3%] y 78 hombres [30,7%]) con una edad media de 56,9 años (rango 19 – 82). La dosis de MODB se incrementó gradualmente en 128 pacientes, obteniendo un total de 382 dosis analizadas. Los sujetos estaban tomando de media 1,45 fármacos antihipertensivos (rango 0 – 5). Se detectaron EA sistémicos en 26 casos (6,8%), incluyendo mareo (3,1%), retención de líquidos (2,6%), malestar general (0,8%), taquicardia (0,8%) y cefalea (0,5%), requiriendo suspensión del MODB en seis casos (1,5%). Los pacientes en tratamiento con doxazosina (p < 0,001) o con tres o más antihipertensivos (p = 0,012) presentaron mayor riesgo de suspensión de MODB. Conclusión El tratamiento con MODB mostró un perfil de seguridad favorable en pacientes con hipertensión o arritmias, similar al de la población general (AU)

[Artíulo traducido] Seguridad de minoxidil oral a dosis bajas en pacientes con hipertensión o arritmias: estudio multicéntrico de 264 pacientes / Safety of Low-Dose Oral Minoxidil in Patients With Hypertension and Arrhythmia: A Multicenter Study of 264 Patients

Antecedentes y objetivo Los efectos adversos sistémicos son una de las principales limitaciones del uso de minoxidil oral a dosis bajas (MODB), especialmente en pacientes con hipertensión arterial o arritmias. El objetivo de este estudio fue evaluar la seguridad de MODB en estos pacientes. Material y método Estudio retrospectivo multicéntrico con pacientes con antecedentes de hipertensión o arritmias tratados con MODB para cualquier tipo de alopecia. Resultados Se incluyó un total de 254 pacientes con hipertensión (176 mujeres [69,3%] y 78 hombres [30,7%]) con una edad media de 56,9 años (rango 19 – 82). La dosis de MODB se incrementó gradualmente en 128 pacientes, obteniendo un total de 382 dosis analizadas. Los sujetos estaban tomando de media 1,45 fármacos antihipertensivos (rango 0 – 5). Se detectaron EA sistémicos en 26 casos (6,8%), incluyendo mareo (3,1%), retención de líquidos (2,6%), malestar general (0,8%), taquicardia (0,8%) y cefalea (0,5%), requiriendo suspensión del MODB en seis casos (1,5%). Los pacientes en tratamiento con doxazosina (p < 0,001) o con tres o más antihipertensivos (p = 0,012) presentaron mayor riesgo de suspensión de MODB. Conclusión El tratamiento con MODB mostró un perfil de seguridad favorable en pacientes con hipertensión o arritmias, similar al de la población general (AU)

Background and objective Systemic adverse effects (AE) are a major concern of low-dose oral minoxidil (LDOM) treatment, especially in patients with arterial hypertension or arrhythmia. The objective of this study was to evaluate the safety of LDOM in patients with hypertension or arrhythmia. Patients and methods Retrospective multicenter study of patients with hypertension or arrhythmia treated with LDOM for any type of alopecia. Results A total of 254 patients with hypertension [176 women (69.3%) and 78 men (30.7%)] with a mean age of 56.9 years (range 19–82) were included. From them, the dose of LDOM was titrated in 128 patients, allowing the analysis of 382 doses. Patients were receiving a mean of 1.45 (range 0–5) antihypertensive drugs. Systemic AE were detected in 26 cases (6.8%) and included lightheadedness (3.1%), fluid retention (2.6%), general malaise (0.8%), tachycardia (0.8%) and headache (0.5%), leading to LDOM discontinuation in 6 cases (1.5%). Prior treatment with doxazosin (P<0.001), or with three or more antihypertensive drugs (P=0.012) was associated with a higher risk of discontinuation of LDOM. Conclusions LDOM treatment showed a favorable safety profile in patients with hypertension or arrhythmia, similar to general population (AU)

Safety of Low-Dose Oral Minoxidil in Patients With Hypertension and Arrhythmia: A Multicenter Study of 264 Patients. / [Artíulo traducido] Seguridad de minoxidil oral a dosis bajas en pacientes con hipertensión o arritmias: estudio multicéntrico de 264 pacientes.

BACKGROUND AND OBJECTIVE: Systemic adverse effects (AE) are a major concern of low-dose oral minoxidil (LDOM) treatment, especially in patients with arterial hypertension or arrhythmia. The objective of this study was to evaluate the safety of LDOM in patients with hypertension or arrhythmia. PATIENTS AND METHODS: Retrospective multicenter study of patients with hypertension or arrhythmia treated with LDOM for any type of alopecia. RESULTS: A total of 254 patients with hypertension [176 women (69.3%) and 78 men (30.7%)] with a mean age of 56.9 years (range 19-82) were included. From them, the dose of LDOM was titrated in 128 patients, allowing the analysis of 382 doses. Patients were receiving a mean of 1.45 (range 0-5) antihypertensive drugs. Systemic AE were detected in 26 cases (6.8%) and included lightheadedness (3.1%), fluid retention (2.6%), general malaise (0.8%), tachycardia (0.8%) and headache (0.5%), leading to LDOM discontinuation in 6 cases (1.5%). Prior treatment with doxazosin (P<0.001), or with three or more antihypertensive drugs (P=0.012) was associated with a higher risk of discontinuation of LDOM. CONCLUSIONS: LDOM treatment showed a favorable safety profile in patients with hypertension or arrhythmia, similar to general population.

Safety of Low-Dose Oral Minoxidil in Patients With Hypertension and Arrhythmia: A Multicenter Study of 264 Patients.

BACKGROUND AND OBJECTIVE: Systemic adverse effects (AE) are a major concern of low-dose oral minoxidil (LDOM) treatment, especially in patients with arterial hypertension or arrhythmia. The objective of this study was to evaluate the safety of LDOM in patients with hypertension or arrhythmia. PATIENTS AND METHODS: Retrospective multicenter study of patients with hypertension or arrhythmia treated with LDOM for any type of alopecia. RESULTS: A total of 254 patients with hypertension [176 women (69.3%) and 78 men (30.7%)] with a mean age of 56.9 years (range 19-82) were included. From them, the dose of LDOM was titrated in 128 patients, allowing the analysis of 382 doses. Patients were receiving a mean of 1.45 (range 0-5) antihypertensive drugs. Systemic AE were detected in 26 cases (6.8%) and included lightheadedness (3.1%), fluid retention (2.6%), general malaise (0.8%), tachycardia (0.8%) and headache (0.5%), leading to LDOM discontinuation in 6 cases (1.5%). Prior treatment with doxazosin (P<0.001), or with three or more antihypertensive drugs (P=0.012) was associated with a higher risk of discontinuation of LDOM. CONCLUSIONS: LDOM treatment showed a favorable safety profile in patients with hypertension or arrhythmia, similar to general population.

Recommendations on the Clinical Management of Androgenetic Alopecia: A Consensus Statement From the Spanish Trichology Group of the Spanish Academy of Dermatology and Venererology (AEDV). / Recomendaciones sobre el manejo clínico de la alopecia androgénica: un documento de consenso del Grupo Español de Tricología de la Academia Española de Dermatología y Venereología.

Androgenetic alopecia can be challenging to treat due to the wide range of available treatments, most of which are not based on evidence from clinical trials. In addition many of the options do not include androgenetic alopecia among the approved indications according to their summaries of product characteristics. A panel of 34 dermatologists from the Spanish Trichology Society of the Spanish Academy of Dermatology and Venereology (AEDV) used the Delphi method to develop a consensus statement on the management of androgenetic alopecia. Over a 2-round process the experts agreed on 138 (86%) of the 160 proposed items, which were structured into 4 blocks of recommendations: general considerations, pharmacologic treatment, procedures and hair transplant, and special cases. The resulting consensus statement based on expert opinion of the scientific evidence can guide professionals in the routine management of androgenetic alopecia.

Sonidegib as a Locally Advanced Basal Cell Carcinoma Therapy in Real-life Clinical Setting: A National Multicentre Study / Sonidegib para el tratamiento del carcinoma basocelular avanzado en práctica clínica real: estudio nacional multicéntrico

Background Basal cell carcinoma (BCC) is the most prevalent cancer. A minority of BCCs have an aggressive behaviour (laBCC) and may require hedgehog pathway inhibitors such as sonidegib as its treatment. Objective To describe the use of sonidegib in a large number of patients and provide more data on its real-life efficacy and safety profile. Methods We conducted a retrospective and multicentric study that included patients treated with sonidegib. Epidemiological, effectiveness and safety data were collected. Results A total of 82 patients with a mean age of 73.9 years were included. Ten patients had Gorlin syndrome. Median treatment duration was 6 months. Median follow-up duration was 34.2 months. Globally, 81.7% of the patients showed clinical improvement (52.4% partial response and 29.3% complete response), 12.2% clinical stability and 6.1% disease progression. There was no statistically significant difference in clinical improvement between the 24h and 48h sonidegib posology. After 6 months of treatment, 48.8% of the patients discontinued sonidegib. Prior vismodegib treatment and recurrent primary BCC were associated with a poorer response to sonidegib. At 6 months of treatment, 68.3% of the patients experienced at least one adverse effect. Conclusion Sonidegib shows good effectiveness and acceptable safety profile in usual clinical practice (AU)

Antecedentes El carcinoma de células basales (CBC) es el cáncer más prevalente. Una minoría de CBC tiene un comportamiento agresivo (laBCC) y puede requerir inhibidores de la vía del erizo, como sonidegib como tratamiento. Objetivo Describir el uso de sonidegib en un gran número de pacientes y aportar más datos sobre su perfil de eficacia y seguridad en la vida real. Métodos Realizamos un estudio retrospectivo y multicéntrico que incluyó pacientes tratados con sonidegib. Se recogieron datos epidemiológicos, de eficacia y de seguridad. Resultados Se incluyeron un total de 82 pacientes con una edad media de 73,9 años. Diez pacientes tenían síndrome de Gorlin. La mediana de duración del tratamiento fue de 6 meses. La mediana de duración del seguimiento fue de 34,2 meses. Globalmente, el 81,7% de los pacientes mostró mejoría clínica (52,4% respuesta parcial y 29,3% respuesta completa), el 12,2% estabilidad clínica y el 6,1% progresión de la enfermedad. No hubo diferencias estadísticamente significativas en la mejoría clínica entre la posología de sonidegib de 24horas y de 48horas. Después de 6 meses de tratamiento, el 48,8% de los pacientes suspendió sonidegib. El tratamiento previo con vismodegib y el CBC primario recurrente se asociaron con una peor respuesta a sonidegib. A los 6 meses de tratamiento el 68,3% de los pacientes experimentó al menos un efecto adverso. Conclusión Sonidegib muestra un perfil de eficacia y seguridad mejor de lo esperado en la práctica clínica habitual (AU)

[Artículo traducido] Sonidegib para el tratamiento del carcinoma basocelular avanzado en práctica clínica real: estudio nacional multicéntrico / Sonidegib as a Locally Advanced Basal Cell Carcinoma Therapy in Real-life Clinical Setting: A National Multicentre Study

Antecedentes El carcinoma de células basales (CBC) es el cáncer más prevalente. Una minoría de CBC tiene un comportamiento agresivo (laBCC) y puede requerir inhibidores de la vía del erizo, como sonidegib como tratamiento. Objetivo Describir el uso de sonidegib en un gran número de pacientes y aportar más datos sobre su perfil de eficacia y seguridad en la vida real. Métodos Realizamos un estudio retrospectivo y multicéntrico que incluyó pacientes tratados con sonidegib. Se recogieron datos epidemiológicos, de eficacia y de seguridad. Resultados Se incluyeron un total de 82 pacientes con una edad media de 73,9 años. Diez pacientes tenían síndrome de Gorlin. La mediana de duración del tratamiento fue de 6 meses. La mediana de duración del seguimiento fue de 34,2 meses. Globalmente, el 81,7% de los pacientes mostró mejoría clínica (52,4% respuesta parcial y 29,3% respuesta completa), el 12,2% estabilidad clínica y el 6,1% progresión de la enfermedad. No hubo diferencias estadísticamente significativas en la mejoría clínica entre la posología de sonidegib de 24horas y de 48horas. Después de 6 meses de tratamiento, el 48,8% de los pacientes suspendió sonidegib. El tratamiento previo con vismodegib y el CBC primario recurrente se asociaron con una peor respuesta a sonidegib. A los 6 meses de tratamiento el 68,3% de los pacientes experimentó al menos un efecto adverso. Conclusión Sonidegib muestra un perfil de eficacia y seguridad mejor de lo esperado en la práctica clínica habitual (AU)

Background Basal cell carcinoma (BCC) is the most prevalent cancer. A minority of BCCs have an aggressive behaviour (laBCC) and may require hedgehog pathway inhibitors such as sonidegib as its treatment. Objective To describe the use of sonidegib in a large number of patients and provide more data on its real-life efficacy and safety profile. Methods We conducted a retrospective and multicentric study that included patients treated with sonidegib. Epidemiological, effectiveness and safety data were collected. Results A total of 82 patients with a mean age of 73.9 years were included. Ten patients had Gorlin syndrome. Median treatment duration was 6 months. Median follow-up duration was 34.2 months. Globally, 81.7% of the patients showed clinical improvement (52.4% partial response and 29.3% complete response), 12.2% clinical stability and 6.1% disease progression. There was no statistically significant difference in clinical improvement between the 24h and 48h sonidegib posology. After 6 months of treatment, 48.8% of the patients discontinued sonidegib. Prior vismodegib treatment and recurrent primary BCC were associated with a poorer response to sonidegib. At 6 months of treatment, 68.3% of the patients experienced at least one adverse effect. Conclusion Sonidegib shows good effectiveness and acceptable safety profile in usual clinical practice (AU)

Sonidegib as a Locally Advanced Basal Cell Carcinoma Therapy in Real-life Clinical Setting: A National Multicentre Study. / [Artículo traducido] Sonidegib para el tratamiento del carcinoma basocelular avanzado en práctica clínica real: estudio nacional multicéntrico.

BACKGROUND: Basal cell carcinoma (BCC) is the most prevalent cancer. A minority of BCCs have an aggressive behaviour (laBCC) and may require hedgehog pathway inhibitors such as sonidegib as its treatment. OBJECTIVE: To describe the use of sonidegib in a large number of patients and provide more data on its real-life efficacy and safety profile. METHODS: We conducted a retrospective and multicentric study that included patients treated with sonidegib. Epidemiological, effectiveness and safety data were collected. RESULTS: A total of 82 patients with a mean age of 73.9 years were included. Ten patients had Gorlin syndrome. Median treatment duration was 6 months. Median follow-up duration was 34.2 months. Globally, 81.7% of the patients showed clinical improvement (52.4% partial response and 29.3% complete response), 12.2% clinical stability and 6.1% disease progression. There was no statistically significant difference in clinical improvement between the 24 h and 48 h sonidegib posology. After 6 months of treatment, 48.8% of the patients discontinued sonidegib. Prior vismodegib treatment and recurrent primary BCC were associated with a poorer response to sonidegib. At 6 months of treatment, 68.3% of the patients experienced at least one adverse effect. CONCLUSION: Sonidegib shows good effectiveness and acceptable safety profile in usual clinical practice.

Sonidegib as a Locally Advanced Basal Cell Carcinoma Therapy in Real-life Clinical Setting: A National Multicentre Study.

BACKGROUND: Basal cell carcinoma (BCC) is the most prevalent cancer. A minority of BCCs have an aggressive behaviour (laBCC) and may require hedgehog pathway inhibitors such as sonidegib as its treatment. OBJECTIVE: To describe the use of sonidegib in a large number of patients and provide more data on its real-life efficacy and safety profile. METHODS: We conducted a retrospective and multicentric study that included patients treated with sonidegib. Epidemiological, effectiveness and safety data were collected. RESULTS: A total of 82 patients with a mean age of 73.9 years were included. Ten patients had Gorlin syndrome. Median treatment duration was 6 months. Median follow-up duration was 34.2 months. Globally, 81.7% of the patients showed clinical improvement (52.4% partial response and 29.3% complete response), 12.2% clinical stability and 6.1% disease progression. There was no statistically significant difference in clinical improvement between the 24h and 48h sonidegib posology. After 6 months of treatment, 48.8% of the patients discontinued sonidegib. Prior vismodegib treatment and recurrent primary BCC were associated with a poorer response to sonidegib. At 6 months of treatment, 68.3% of the patients experienced at least one adverse effect. CONCLUSION: Sonidegib shows good effectiveness and acceptable safety profile in usual clinical practice.